TY - JOUR
T1 - Novel Budesonide Suppository and Standard Budesonide Rectal Foam Induce High Rates of Clinical Remission and Mucosal Healing in Active Ulcerative Proctitis
T2 - a Randomised, Controlled, Non-inferiority Trial
AU - Kruis, Wolfgang
AU - Siegmund, Britta
AU - Lesniakowski, Konrad
AU - Simanenkov, Vladimir
AU - Khimion, Ludmila
AU - Sobon, Marcin
AU - Delmans, Glebs
AU - Maksyashina, Svetlana V.
AU - Sablin, Oleg A.
AU - Pokrotnieks, Juris
AU - Mostovoy, Yuriy
AU - Datsenko, Olena
AU - Abdulkhakov, Sayar
AU - Dorofeyev, Andriy
AU - Levchenko, Olena
AU - Alexeeva, Olga
AU - Andreev, Pavel
AU - Kolesnik, Ivan P.
AU - Mihaly, Emese
AU - Abrahamovych, Orest
AU - Baluta, Malgorzata
AU - Kharchenko, Nataliia
AU - Viacheslav, Neshta
AU - Uspenskiy, Yury
AU - Vieth, Michael
AU - Mohrbacher, Ralf
AU - Mueller, Ralph
AU - Greinwald, Roland
N1 - Publisher Copyright:
© The Author(s) 2022. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation.
PY - 2022/11/23
Y1 - 2022/11/23
N2 - BACKGROUND AND AIMS: Proctitis is the least extensive type of ulcerative colitis, for which rectal therapy is rarely studied and is underused. This study evaluated the efficacy, safety, and patient's preference of a novel formulation of budesonide suppository 4 mg, compared with a commercially available budesonide rectal foam 2 mg, for the treatment of mild to moderate ulcerative proctitis. METHODS: This was a randomised, double-blind, double-dummy, active-controlled trial. Patients were randomly assigned in a 1:1 ratio to receive either budesonide 4 mg suppository or budesonide 2 mg foam once daily for 8 weeks. The co-primary endpoints were changes from baseline to Week 8 in clinical symptoms, for which clinical remission was defined as having a modified Ulcerative Colitis-Disease Activity Index [UC-DAI] subscore for stool frequency of 0 or 1 and a subscore for rectal bleeding of 0, and mucosal healing, defined as having a modified UC-DAI subscore for mucosal appearance of 0 or 1. Using a more stringent criterion, we additionally analysed deepened mucosal healing, which was defined as a mucosal appearance subscore of 0. Patient's preference, physician's global assessment, and quality of life were also assessed and analysed. RESULTS: Overall, 286 and 291 patients were included in the 4 mg suppository and 2 mg foam groups, respectively. Budesonide 4 mg suppository met the prespecified criterion for non-inferiority to the 2 mg foam in both co-primary endpoints of clinical remission and mucosal healing. Secondary endpoints consistently supported the non-inferiority of the suppository. Trends in favour of the suppository were observed in the subgroup of mesalazine non-responders. More patients reported a preference for the suppository over rectal foam. CONCLUSIONS: In patients with ulcerative proctitis, budesonide 4 mg suppository was non-inferior to budesonide 2 mg foam in efficacy, and both were safe and well tolerated.
AB - BACKGROUND AND AIMS: Proctitis is the least extensive type of ulcerative colitis, for which rectal therapy is rarely studied and is underused. This study evaluated the efficacy, safety, and patient's preference of a novel formulation of budesonide suppository 4 mg, compared with a commercially available budesonide rectal foam 2 mg, for the treatment of mild to moderate ulcerative proctitis. METHODS: This was a randomised, double-blind, double-dummy, active-controlled trial. Patients were randomly assigned in a 1:1 ratio to receive either budesonide 4 mg suppository or budesonide 2 mg foam once daily for 8 weeks. The co-primary endpoints were changes from baseline to Week 8 in clinical symptoms, for which clinical remission was defined as having a modified Ulcerative Colitis-Disease Activity Index [UC-DAI] subscore for stool frequency of 0 or 1 and a subscore for rectal bleeding of 0, and mucosal healing, defined as having a modified UC-DAI subscore for mucosal appearance of 0 or 1. Using a more stringent criterion, we additionally analysed deepened mucosal healing, which was defined as a mucosal appearance subscore of 0. Patient's preference, physician's global assessment, and quality of life were also assessed and analysed. RESULTS: Overall, 286 and 291 patients were included in the 4 mg suppository and 2 mg foam groups, respectively. Budesonide 4 mg suppository met the prespecified criterion for non-inferiority to the 2 mg foam in both co-primary endpoints of clinical remission and mucosal healing. Secondary endpoints consistently supported the non-inferiority of the suppository. Trends in favour of the suppository were observed in the subgroup of mesalazine non-responders. More patients reported a preference for the suppository over rectal foam. CONCLUSIONS: In patients with ulcerative proctitis, budesonide 4 mg suppository was non-inferior to budesonide 2 mg foam in efficacy, and both were safe and well tolerated.
KW - budesonide
KW - Clinical trials
KW - rectal foam
KW - rectal suppository
KW - ulcerative proctitis
UR - http://www.scopus.com/inward/record.url?scp=85142940215&partnerID=8YFLogxK
U2 - 10.1093/ecco-jcc/jjac081
DO - 10.1093/ecco-jcc/jjac081
M3 - Article
C2 - 35709376
AN - SCOPUS:85142940215
SN - 1873-9946
VL - 16
SP - 1714
EP - 1724
JO - Journal of Crohn's and Colitis
JF - Journal of Crohn's and Colitis
IS - 11
ER -